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Bethesda,
Maryland20892

Purpose:

Some drugs have the ability to push stem cells (the cells responsible for producing new cell
types) out of the bone marrow and into the blood stream. The steps involved in this process
are still poorly understood. However, a better understanding of this process could lead to
improved results in transplantation, cancer treatment, and contribute to the development of
new genetic therapies for a wide variety of disorders.
In this study researchers plan to compare two different treatments, both that mobilize
(push) stem cells out of the bone marrow into the blood stream. In addition, researchers
will attempt to determine which is the most efficient at mobilizing blood cells of patients
with multiple myeloma.
Information and knowledge gained from this study will help to design future transplantation
and genetic therapy research studies.

Study summary:

Some drugs, such as hematopoietic cytokines, result in mobilization of primitive stem cells
out of the bone marrow space and into the blood, but the mechanisms of this process are
still poorly understood. A better understanding of this process could greatly improve
clinical results in transplantation, cancer treatment, and potentially genetic therapy of a
wide variety of disorders. In this protocol, we will study two different mobilization
treatments and compare how efficient they are at increasing the number of primitive cells in
the blood in patients with multiple myeloma. These cells will be collected by apheresis,
and used for autologous transplantation following high dose chemotherapy. This aggressive
approach to treatment in multiple myeloma has been shown to improve remission rates and
survival without active disease. The use of a larger number of blood stem cells may
decrease the toxicity associated with the procedure. In the research laboratory, we will
study a number of characteristics of the primitive cells in the blood and the bone marrow
after treatment with the mobilizing drugs. These studies will help us to design future
transplantation and genetic therapy protocols.

Criteria:

INCLUSION CRITERIA
Age 70 or younger at time of pretransplant evaluation.
An established diagnosis of multiple myeloma.
ECOG performance status of 0 or 1 and a life-expectancy of greater than 6 months.
Marrow cellularity greater than 20 percent, with less than or equal to 30 percent plasma
cells within one month of study entry.
Platelet count greater than 100,000/ul, ANC greater than 1200/ul.
Demonstration of a partial or complete response to initial or salvage therapy (a minimum
of a 50 percent reduction in the detectable serum paraprotein or at least a 90 percent
reduction in the detectable urine monoclonal light chains, stable for at least four weeks
prior to entry into study). A cumulative total of less than or equal to 6 cycles of
regimens containing alkylating agents.
Bilirubin less than 2.0, transaminases less than 2x upper limit of normal, serum
creatinine less than 3.0.
Ability and willingness to give informed consent.
EXCLUSION CRITERIA
Prior bone marrow or PBSC transplant.
HIV positivity.
Extensive marrow fibrosis, non-aspirable marrow, myelodysplastic changes or greater than
30 percent marrow plasma cells.
Prior treatment with greater than 6 cycles of chemotherapy regimens containing alkylating
agents such as melphalan, cyclophosphamide or BCNU.
History of another malignancy within 5 years of protocol entry, with the exception of
localized carcinomas cured by surgical resection such as basal cell carcinoma, stage I
breast or bladder cancer, or in situ carcinoma of the cervix.
Significant nonmalignant disease including uncontrolled hypertension, unstable angina,
congestive heart failure, poorly controlled diabetes, coronary angioplasty within 6
months, myocardial infarction within 6 months, uncontrolled arrhythmias, or any other
medical condition felt by the principal investigator to unduly increase the risk of
autologous transplantation.
Significant allergy history: these criteria will be assessed via the Allergy History CRF
Screening Form.
Patients with any of the following concurrent conditions are not eligible:
No history of positive allergy tests to insect venoms (either skin or RAST).
No history of seasonal or recurrent asthma within the preceding 10 years.
No asthmatic symptoms (e.g. wheezing) related to a current respiratory tract infection.
No anaphylactic/anaphylactoid-type event manifested by disseminated urticaria, laryngeal
edema, and/or bronchospasm (or for example: food, insect bites, etc.) Patients with drug
allergies, manifest solely by rash, and/or urticaria are not excluded.
No history of angioedema or recurrent urticaria (an isolated episode of urticaria is not a
contraindication).
No active infection (including those with current symptoms of bronchoconstriction), or
fever greater than or equal to 38.2 degrees Celsius.
No known allergy to E. coli-derived products.
No concurrent use of beta adrenergic blocking agents.
No concurrent use of other investigative agents.
No pregnancy or breast-feeding. Men and women of child-bearing potential, admitted to the
trial are to be advised to take adequate measures to prevent conception.
Patients maintained on interferon, chemotherapy or hematopoietic growth factors must have
these treatments discontinued for at least four weeks prior to entry into this study.

NCT ID:

NCT00001750

Primary Contact:

N/A

Backup Contact:

N/A

Location Contact:

Bethesda, Maryland 20892United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: September 26, 2017

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